Stents are small, intricately cut tubes, generally made of materials such as stainless steel. Cardiovascular stents are permanently placed in a blood vessel to act as scaffolding to keep an occluded artery open. In use, cardiovascular stents are inserted into the artery on a catheter and are typically deployed by expanding a very small balloon at the end of the catheter upon which the stent is mounted.
Cardiovascular stents must meet stringent requirements to work properly. If the stent contains any rough or sharp edges, it will damage blood cells or the blood vessel in which it is inserted. This can lead to further atherosclerotic plaquing, emboli or thrombi, and result in potentially life threatening situations.
This invention relates to an illumination and inspection system for stents and other similar parts that take the form of a small precisely machined tube.
Lasers are typically used to cut stents. This process, while highly precise, can occasionally produce defective parts. Stents tend to be fairly small, with diameters approximating 1 mm. After processing, the individual cut features on a stent range from 50 to 200 microns in size. Accordingly, small changes in manufacturing process parameters such as laser power, tubing diameter, or mechanical jitter can cause defects. Such defects may include an out of tolerance feature size or a malformed feature.
Since stents are used in the heart and other critical areas of blood flow, a failure in the function of the stent could be life threatening. Thus, manufacturers of stents typically employ 100% inspection procedures. A human operator utilizing a 50× optical power stereo-microscope typically inspects for visual defects. Dimensional inspection is typically done by a human operator utilizing a Profile Projector. Alternatively, this inspection can be done automatically by utilizing a vision system.
The problems associated with either the manual or automatic approaches to inspection are numerous. First, human error makes visual inspection of products less than completely effective. Also, such manual inspection is relatively slow and thus a relatively costly aspect of the manufacturing process. Furthermore, the pass/fail criteria of the profile projector using overlays, as is typically employed in manual inspection, does not generally provide any numeric dimensional data that would otherwise be useful for process control. In addition, when inspecting the outer and the inner surface of a stent, both surfaces are typically illuminated at the same time, leading to reflexes that will prevent an automatic inspection.
U.S. Pat. No. 6,606,403 B2 discloses an automatic system for illuminating, inspecting and measuring stents and other precision cut tubes and components made of a linear array electronic camera with a lens, a light source to provide necessary illumination to create an image on the linear array camera, a mandrel onto which the tube is mounted during inspection, a rotary stage for rotating the mandrel, and a computer based electronic imaging system that creates a line-by-line image of the stent as it rotates under the camera. However, the system is only able to inspect the outer surface of the stent.